[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Paul A Breslin\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":47},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":5},"100526612","phase-1-fortified-oral-rehydration-therapy-for-pediatric-diarrhea-100526612",false,"NCT06137014","Fortified Oral Rehydration Therapy for Pediatric Diarrhea","Reduction of Severity and Duration of Pediatric Gastroenteritis Through Amino Acid Fortified Oral Rehydration Therapy","fORT","Inclusion Criteria:\n\n* Between the ages of 6 months and 5 years.\n* Experiencing mild to moderate acute gastroenteritis for less than two (2) days before admission to Pediatric Emergency Department.\n* Diarrhea presumed infectious\n\nExclusion Criteria:\n\n* Severe gastroenteritis with moderate to severe dehydration\n* Requiring inpatient care\n* Requiring antibiotics\n* Requiring IV rehydration\n* History of chronic diarrhea\n* Presenting with diarrhea for greater than 2 days prior to admission\n* Allergy to any of the ingredients in the study products\n* Inborn metabolic disorder of amino acids\n* Receives post-pyloric feedings","ALL","6 Months","5 Years",{"count":21,"type":22},72,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","The goal of this clinical trial is to compare amino acid-fortified oral rehydration therapy (ORT) to the standard of care ORT in pediatric patients with acute gastroenteritis (AGE). The main questions it aims to answer are:\n\n* can amino acid-fortified ORT reduce the duration and severity of AGE compared to standard of care ORT?\n* can amino acid-fortified ORT increase the secretion of antimicrobial peptides in the gastrointestinal tract compared to standard of care ORT?\n\nParticipants will be assigned to the experimental treatment (amino acid-fortified ORT) or the standard of care ORT and their disease severity, duration, and stool antimicrobial peptide content.",[29],"Acute Gastroenteritis",[31,32,33,34],"Gastroenteritis","Intestinal Diseases","Pediatric Diseases","Diarrhea, Infantile","RECRUITING","2026-02-09",{"date":38,"type":39},"2026-02-12","ACTUAL",{"date":41,"type":39},"2024-06-01",{"date":43,"type":22},"2027-06",{"name":45,"class":46},"Paul A Breslin","OTHER",""]